- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02025712
Exemestane Plus Everolimus for Hormone-receptor Positive Metastatic Breast Cancer
December 29, 2013 updated by: Organisation for Oncology and Translational Research
A Phase II Open-label Pilot Study Evaluating the Maintenance Therapy With Exemestane Plus Everolimus After Induction Chemotherapy in Patients With Hormone-receptor Positive Metastatic Breast Cancer
The purpose of this study is to determine whether exemestane plus everolimus are effective in the treatment of patients who have achieved disease stabilization after induction chemotherapy for hormone-receptor positive metastatic breast cancer.
Study Overview
Status
Unknown
Intervention / Treatment
Detailed Description
Postmenopausal women with HR-positive, HER2-negative metastatic breast cancer achieving clinical benefit after the induction chemotherapy for visceral disease with sign(s) and/or symptom(s) will be recruited to receive study the maintenance treatment of everolimus plus exemestane.
Study Type
Interventional
Enrollment (Anticipated)
35
Phase
- Phase 2
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Hong Kong, China
- UNIMED Medical Institute
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Contact:
- Louis Chow
- Phone Number: (852)28610286
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Principal Investigator:
- Louis Chow
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years and older (ADULT, OLDER_ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- Postmenopausal women as defined in the protocol page 9;
- Histologically and/or cytologically confirmed invasive breast cancer with stage IV disease according to AJCC;
- Confirmed ER/PR-positive, and HER-2 negative tumor;
- Disease progression on or following prior endocrine therapy with tamoxifen or non-steroidal aromatase inhibitor, as defined in protocol, prior to standard of care (SOC) induction chemotherapy
- Patient with documented evidence of visceral disease (including but not limited to hepatic involvement and pulmonary lymphangitic spread of tumor) with sign(s) and/or symptom(s) prior to SOC induction chemotherapy should achieve disease stabilization after the SOC induction chemotherapy, confirmed upon 2 consecutive routine tumor assessments;
- ECOG performance status ≤ 2 or Karnofsky performance status ≥ 50% prior to the start of study treatment;
- Adequate organ function prior to the start of study treatment as defined in the protocol;
- Able to swallow and retain oral medication;
- Able to give written informed consent;
Exclusion Criteria:
- Male patient;
- Metastatic disease limited to the bone or soft tissues only and with no history of other visceral metastases;
- History of brain or other CNS metastases;
- Previous treatment with exemestane, unless exemestane was administered in the adjuvant setting and stopped >1 year before metastatic relapse;
- Untreated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC - or - treated with SOC chemotherapy for invasive breast cancer with stage IV disease according to AJCC without clinical benefit;
- History of neurological or psychiatric disorders;
- Any serious cardiovascular diseases in the previous 6 months;
- Impairment of gastrointestinal function or gastrointestinal disease;
- Patients with uncontrolled infection;
- Patients with an active, bleeding diathesis or on oral anti-vitamin K medication (except low dose coumadin defined as 1 mg a day);
- Chronic treatment with systemic steroids or another immunosuppressive agent;
- Patients with a pre-existing peripheral neuropathy > grade 1;
- Patients who are hepatitis B and/or hepatitis C carriers;
- Known human immunodeficiency virus infection;
- Prior exposure to mTOR inhibitors;
- Hypersensitivity to rapamycin or other similar compounds;
- Patients taking medications known to be inhibitors or inducers of CYP3A4 and/or PgP will not be included in this study;
- Prior treatment with any investigational agent within the preceding 4 weeks;
- Other conditions in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Other protocol-defined inclusion/exclusion criteria may apply.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: NA
- Interventional Model: SINGLE_GROUP
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: Exemestane plus Everolimus
Exemestane 25 mg daily in combination with Everolimus 10 mg daily until disease progression or intolerable toxicity
|
Commercially available exemestane was supplied to sites as 25-mg tablets according to local regulations.
Other Names:
Everolimus was administered by continuous oral dosing of two 5-mg tablets or one 10-mg tablets.
Other Names:
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Progression Free Survival
Time Frame: Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
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defined as from date of treatment initiation with everolimus plus exemestane to the date of progression or death if no documented disease progression
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Every 8 weeks in the first 24 weeks of treatment and every 12 weeks thereafter, up to 8 months (estimated)
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Response rate
Time Frame: Every 8 weeks, up to 8 months (estimated)
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Every 8 weeks, up to 8 months (estimated)
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Clinical benefit rate
Time Frame: Every 8 weeks, up to 8 months (estimated)
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Every 8 weeks, up to 8 months (estimated)
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Overall survival
Time Frame: date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
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date of treatment initiation with everolimus plus exemestane until the date of death, censored at the last date known alive, whichever came first, assessed up to 32 months
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Incidence of Adverse Events (AEs)/Serious Adverse Events (SAEs)
Time Frame: Continuous during the study, up to 28 days after the last treatment
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Continuous during the study, up to 28 days after the last treatment
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Louis Chow, Organisation for Oncology and Translational Research
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Primary Completion (ANTICIPATED)
August 1, 2016
Study Registration Dates
First Submitted
December 16, 2013
First Submitted That Met QC Criteria
December 29, 2013
First Posted (ESTIMATE)
January 1, 2014
Study Record Updates
Last Update Posted (ESTIMATE)
January 1, 2014
Last Update Submitted That Met QC Criteria
December 29, 2013
Last Verified
December 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Skin Diseases
- Neoplasms by Site
- Breast Diseases
- Neoplasms
- Breast Neoplasms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Enzyme Inhibitors
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Hormone Antagonists
- Aromatase Inhibitors
- Steroid Synthesis Inhibitors
- Estrogen Antagonists
- Everolimus
- Exemestane
Other Study ID Numbers
- M004/EXE-EVE
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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